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A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma

Primary Purpose

Multiple Myeloma, Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Meloxicam
Filgrastim
Sponsored by
Sherif S. Farag
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:

  1. Has provided written informed consent prior to completing any study procedures.

  2. Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols.

    1. Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria.50

    2. Non-Hodgkin's lymphoma must be in either first or second partial response or better and have any one of the following histologies:

      • Diffuse large B cell lymphoma
      • Transformed lymphoma
      • Mantle cell lymphoma
      • Follicular lymphoma (any grade)
      • Peripheral T cell lymphoma
  3. Age ≥18 to ≤75 years at time of consent.
  4. Karnofsky performance status of at least 70%.

  5. Adequate organ function defined as:

    1. Left ventricular ejection fraction ≥45%
    2. Corrected DLCO ≥50%
    3. Serum bilirubin, AST (aspartate aminotransferase) and ALT(alanine aminotransferase) ≤ twice the upper limit of normal
    4. Serum creatinine ≤ 2.0 mg/dl
    5. Urine M-protein ≤1 g/24 hours (MM patients only)
  6. No prior attempt at mobilizing PBSC.
  7. Patients must be at least 4 weeks from last cytotoxic chemotherapy (including alkylating, anthracyclines, epipodophylatoxins, and platinum drugs), or immunomodulatory drugs (including lenalidomide or pomalidomide, or related derivatives) at time of treatment on this protocol.
  8. Patients must be at least 2 weeks from last treatment with a proteasome inhibitor (e.g., bortezomib, carfilzomib) at time of treatment on this protocol.
  9. Patients must be negative for HIV.

  10. Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent.

    1. Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence (no sexual intercourse) or surgical sterilization.

Exclusion Criteria:

Exclude a patient if any of the following conditions are observed:

  1. Patients must not have received radiation therapy within the past 4 weeks, and not to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones).
  2. Patients must not have active central nervous system involvement.
  3. Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant.
  4. Patients must not have received prior bone seeking radionuclides.
  5. Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study.
  6. Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol.

  7. Patients must not have nor had active or recent peptic ulcer disease within the past 6 months.

    a) Patients with active significant symptoms of dyspepsia will be excluded.

  8. Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.

Sites / Locations

  • Indiana University Melvin and Bren Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.

Outcomes

Primary Outcome Measures

Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with >= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with >= 2.5x106 CD34 cells/kg in the first day's apheresis.

Secondary Outcome Measures

Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10^6cells/kg)) at each time point collected during Cycle 2.
Time to Neutrophil Engraftment
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. The median and 95% confidence intervals will be provided. Only patients with neutrophil engraftment will be included.
Time to Platelet Engraftment
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals will be provided. Only patients achieving platelet engraftment will be included.

Full Information

First Posted
February 20, 2014
Last Updated
February 2, 2021
Sponsor
Sherif S. Farag
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02078102
Brief Title
A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
Official Title
A Phase II Trial of Prostaglandin E2 Inhibition, Using Meloxicam, Plus Filgrastim for Mobilization of Autologous Peripheral Blood Stem Cells in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2014 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherif S. Farag
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial is an open label Simon optimal two-stage Phase II trial of fixed doses of oral meloxicam and subcutaneous filgrastim to assess the safety and efficacy in mobilizing autologous peripheral blood stem cells (PBSC) from multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) patients planning to undergo high-dose chemotherapy with stem cell support. Clinical data regarding the cellular composition and function of the graft mobilized by this combination will be obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Other Intervention Name(s)
Mobic
Intervention Description
15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Neupogen
Intervention Description
Filgrastim will be subcutaneously injected in one or two sites at home.
Primary Outcome Measure Information:
Title
Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
Description
Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with >= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with >= 2.5x106 CD34 cells/kg in the first day's apheresis.
Time Frame
within 100 days of transplant
Secondary Outcome Measure Information:
Title
Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
Description
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame
within 100 days of transplant
Title
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Description
Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10^6cells/kg)) at each time point collected during Cycle 2.
Time Frame
Cycle 2, Days 1-4, within 100 days of transplant
Title
Time to Neutrophil Engraftment
Description
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. The median and 95% confidence intervals will be provided. Only patients with neutrophil engraftment will be included.
Time Frame
within 100 days of transplant
Title
Time to Platelet Engraftment
Description
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals will be provided. Only patients achieving platelet engraftment will be included.
Time Frame
within 100 days of transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study: Has provided written informed consent prior to completing any study procedures. Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols. Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria.50 Non-Hodgkin's lymphoma must be in either first or second partial response or better and have any one of the following histologies: Diffuse large B cell lymphoma Transformed lymphoma Mantle cell lymphoma Follicular lymphoma (any grade) Peripheral T cell lymphoma Age ≥18 to ≤75 years at time of consent. Karnofsky performance status of at least 70%. Adequate organ function defined as: Left ventricular ejection fraction ≥45% Corrected DLCO ≥50% Serum bilirubin, AST (aspartate aminotransferase) and ALT(alanine aminotransferase) ≤ twice the upper limit of normal Serum creatinine ≤ 2.0 mg/dl Urine M-protein ≤1 g/24 hours (MM patients only) No prior attempt at mobilizing PBSC. Patients must be at least 4 weeks from last cytotoxic chemotherapy (including alkylating, anthracyclines, epipodophylatoxins, and platinum drugs), or immunomodulatory drugs (including lenalidomide or pomalidomide, or related derivatives) at time of treatment on this protocol. Patients must be at least 2 weeks from last treatment with a proteasome inhibitor (e.g., bortezomib, carfilzomib) at time of treatment on this protocol. Patients must be negative for HIV. Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent. Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence (no sexual intercourse) or surgical sterilization. Exclusion Criteria: Exclude a patient if any of the following conditions are observed: Patients must not have received radiation therapy within the past 4 weeks, and not to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones). Patients must not have active central nervous system involvement. Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant. Patients must not have received prior bone seeking radionuclides. Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study. Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol. Patients must not have nor had active or recent peptic ulcer disease within the past 6 months. a) Patients with active significant symptoms of dyspepsia will be excluded. Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif Farag, M.D., Ph.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34510361
Citation
Patterson AM, Zhang S, Liu L, Li H, Singh P, Liu Y, Farag SS, Pelus LM. Meloxicam with Filgrastim may Reduce Oxidative Stress in Hematopoietic Progenitor Cells during Mobilization of Autologous Peripheral Blood Stem Cells in Patients with Multiple Myeloma. Stem Cell Rev Rep. 2021 Dec;17(6):2124-2138. doi: 10.1007/s12015-021-10259-y. Epub 2021 Sep 12.
Results Reference
derived

Learn more about this trial

A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma

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